• Adverse Event Reporting: “Over the Counter” Doesn’t Mean “Off the Hook”

    As part of its mission to protect the public health, the FDA monitors the safety of drug products marketed in the United States. This is accomplished through laws enacted by Congress as well as regulations established by the agency that require the pharmaceutical industry to document and, as applicable, report adverse events experienced by both patients and consumers when using their products. For OTC drugs that are not marketed under an NDA or ANDA, documentation of adverse events at one time ... read more
  • Dust Due Diligence: Using a Safe API Substitute to Test if a Collection System Can Handle the Job

    Is your dust collection system effectively controlling hazardous solid dose production dust? If you’re not sure, there’s a way to test the system to learn if it is potentially exposing employees to dangerous air-borne particles—without putting your employees at risk. Conducting surrogate testing using a safe API substitute can help you determine if your prospective or current dust collector can meet the challenges of capturing particulates generated during production. read more
  • Track & Trace Roundtable

    What can companies do to improve their Track and Trace capabilities? read more
  • Getting Granular: Supply Chain Issues May Prompt Supplement ‘Finishing’ In-House

    COVID-19 has been a blessing and a curse to many industries. There is no doubt that the current and future outlook for nutraceutical companies manufacturing capsules and tablets will continue to flourish, but what challenges still face this burgeoning market? Globally there is a tendency for manufacturers of finished dose nutraceuticals to rely on excipient providers and other Third Party organizations to granulate various components of their formulations. This over-reliance on outside parties ... read more